INHIBACE TAB 1MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CILAZAPRIL

Available from:

HOFFMANN-LA ROCHE LIMITED

ATC code:

C09AA08

INN (International Name):

CILAZAPRIL

Dosage:

1MG

Pharmaceutical form:

TABLET

Composition:

CILAZAPRIL 1MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0122806001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-07-21

Summary of Product characteristics

PRODUCT MONOGRAPH
Inhibace
®
(cilazapril)
Tablets
1.0, 2.5, 5.0 mg
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
Hoffmann-La Roche Limited
Date of Revision:
2455 Meadowpine Boulevard_ _
February 10, 2009
Mississauga, Ontario L5N 6L7
www.rochecanada.com
Submission Control No: 125788
®
Registered Trade-Mark
©
Copyright 1993 - 2008 Hoffmann-La Roche Ltd
CDS 2.0
INHIBACE
®
„ PAGE 2
PRODUCT MONOGRAPH
Inhibace
®
(Cilazapril)
Tablets 1.0, 2.5, 5.0 mg
THERAPEUTIC CLASSIFICATION
Angiotensin Converting Enzyme Inhibitor
ACTIONS AND CLINICAL PHARMACOLOGY
INHIBACE (cilazapril) is an angiotensin converting enzyme (ACE)
inhibitor, which is used in the
treatment of hypertension and congestive heart failure.
INHIBACE suppresses the renin-angiotensin-aldosterone system and
thereby reduces both
supine and standing systolic and diastolic blood pressures. Renin is
an enzyme that is released
by the kidneys into the circulation to stimulate the production of
angiotensin I, an inactive
decapeptide. Angiotensin I is converted by angiotensin converting
enzyme (ACE) to
angiotensin II, a potent vasoconstrictor. Angiotensin II also
stimulates aldosterone secretion,
leading to sodium and fluid retention. After absorption, cilazapril, a
pro-drug, is hydrolysed to
cilazaprilat, the active metabolite, which prevents the conversion of
angiotensin I to
angiotensin II by inhibition of ACE. Following the administration of
INHIBACE, plasma ACE
activity is inhibited more than 90% within two hours at therapeutic
doses. Plasma renin activity
(PRA) and angiotensin I concentrations are increased and angiotensin
II concentrations and
aldosterone secretion are decreased. The increase in PRA comes as a
result of the loss of
negative feedback on renin release caused by the reduction in
angiotensin II. The decreased
aldosterone secretion may lead to small increases in serum potassium
along with sodium and
fluid loss. In patients with normal renal function, serum potassium
usually remains within the
normal range during INHIBACE treatment. Mean serum potassium v